Multi-conduit balloon catheter

ABSTRACT

A suctioning and irrigating sinus balloon catheter is provided for treating a patient&#39;s paranasal sinus system, including dilating prepared openings, and natural ostia and ducts and excising sinus cavities and choana. The catheter has a number of fluid carrying conduits to provide irrigation, suction and inflation/deflation to the distally mounted balloon. The catheters have sufficient stiffness and column strength that the balloon carrying distal segment of the catheter can be pushed into the prepared opening, natural ostium or duct, choana or sinus to be excised. Some catheters can be hand bendable by the surgeon. Some catheters provide the capability of threading an endoscope through one of the conduits. The methods use the balloon catheters to dilate prepared openings to selected parts of the sinus system, to dilate natural ostia and ducts of the sinus system, choana, and/or to dilate sinus cavities to remove them.

PRIOR APPLICATION

The present application is a continuation-in-part of U.S. patentapplication Ser. No. 11/233,955 filed Sep. 23, 2005 now abandoned.

FIELD OF THE INVENTION

This invention relates to balloon catheters and methods using suchcatheters for treating paranasal sinuses.

BACKGROUND

To fully understand the invention, it is necessary to consider theanatomy and physiology of the nasal and sinus system. FIGS. 4-17, whichshow various method steps described later, also show important featuresof sinus anatomy. The maxillary sinus 21 lies lateral to the nasalcavity 38, inferior to the eye orbit 23 and superior to the palate orroof of the mouth. The medial wall of the maxillary sinus forms thelateral nasal wall 44 inferiorly. The frontal sinus 35 (FIG. 16) liesabove the orbit and its floor is formed by the frontal bone and iscontiguous with part of the orbital roof. The right and left frontalsinuses are divided by the interfrontal septum. The frontal sinus drainsinto the nasal cavity and its outflow tract is in the inferomedialsinus, which connects to the frontonasal duct 36. Frontonasal duct 36empties into the nasal cavity through lateral nasal wall 44 under themiddle turbinate 20.

The ethmoid sinus is divided into anterior and posterior ethmoid aircells 29 and 31. The ethmoid sinus consists of multiple spaces or cellsdivided by thin bony septae. The ethmoid sinus is contained in theethmoid bone. The lateral wall of the ethmoid sinus composes the medialwall of the orbit. The medial wall of the ethmoid sinus composes thelateral wall 44 of the nasal cavity superiorly. Anterior ethmoid aircells 29 drain through lateral nasal wall 44 into the middle meatus 22beneath middle turbinate 20.

The sphenoid sinus 39 (FIG. 15) is posterior to the ethmoid sinus 29 and31. Sphenoid sinus 39 has a lateral wall that is adjacent to the opticnerve, carotid artery, and cavernous sinus. The floor of sphenoid sinus39 lies above maxillary sinus 21 and pterygopalatine fossa. Lateralnasal wall 44 is partially covered by inferior 46, middle 20, andsuperior 17 turbinates.

The choanae (FIG. 17) are the posterior openings of the nose. Eachchoana 299 is separated by the vomer bone. The lateral border of thechoana is formed by the posterior end of the turbinates.

Sinus physiology will now be considered. The mucosa of nasal cavity 38contains secretory elements (mucosal glands and goblet cells) and adense ciliary layer. The paranasal sinuses are covered by a similarmucosa, although the secretory cells and cilia may be sparser in themore remote areas of the sinuses. The secretory cells produce a largevolume of mucus that is normally actively transported by the cilia(mucociliary transport) in a specific pattern (not a gravity dependantpattern) from the sinus through the opening between the sinus and thenasal cavity (sinus ostium). Cellular debris and bacteria aretransported in the mucus from the sinus cavity through the ostium intothe nose.

Inflammation of the sinus and nasal mucosa causes hyperemia, lymphaticswelling, stasis in the blood and lymphatic pathways and leads toincreased secretion of mucus and reduced mucociliary transport. Theinflammation may be caused by allergies, noxious agents, nasal polyps,and other factors. Over time, there is a pathologic increase ininflammatory cells, ground substance, and fibers with a permanentdisruption of mucociliary transport and lymphatic drainage. Anobstruction of the narrow ducts and ostia between the paranasal sinusesand nasal cavity develops, resulting in a vicious cycle of increasedsecretions, edema, and ultimately organized connective tissue andmucosal hyperplasia. Bacteria are not cleared from the sinuses andmultiply in the fertile inflammatory environment worsening the chronicsinus inflammation (sinusitis).

Treatment with antibiotics, corticosteroids in nasal sprays orsystemically, and antihistamines may result in resolution of sinusitis.However some patients become resistant to medical treatment and surgerybecomes necessary.

Modern sinus surgery is usually performed endoscopically and is based onthe principle of restoring patency of the sinus ducts and ostia byenlarging the opening and allowing mucociliay clearance of mucus fromthe sinus into the nose to resume. If mucociliary clearance isre-established, then the inflammatory changes in the sinus mucosadescribed above will resolve. In classic sinus surgery, an incision wasmade along the side of the nose in the medial canthus to access theethmoid or sphenoid sinuses. This incision could be extended to beneaththe medial half of the brow to also access the frontal sinus. Anincision through the gums above the upper teeth and creation of a largebony opening in the maxilla with excision of large areas of sinus mucosawas used to perform maxillary sinus surgery. A large opening was createdthrough the medial wall of the maxillary sinus into the nose in theinferior meatus (maxillary antrostomy) to allow postoperative drainageof the sinus.

The development of endoscopic sinus surgery allowed sinus surgery to beperformed from an intranasal approach, thus eliminating the need forexternal incisions, the creation of very large bony openings, andreducing morbidity. However, endoscopic sinus surgery requires theexcision of large areas of bone and nasal mucosa and has reportedcomplications of blindness from damage to the optic nerve, double visionfrom damage to the orbit and medial rectus muscle, damage to thenasolacrimal duct resulting in tearing and dacryocstitis, leakage ofcerebrospinal fluid and infection of the brain and meninges, loss of thesense of taste, infection of the skull base, hemorrhage from the carotidartery or other blood vessels, and pain and neuralgia of the face andscalp.

As shown in U.S. Pat. Nos. 5,021,043 and 5,169,043, I have previouslyco-invented balloon catheters for use in the lacrimal system. As shownin my U.S. patent application Ser. No. 10/259,630 and published underU.S. Pat. Pub. No. 20040064083, I teach that a balloon catheter can beintroduced transnasally to treat the lacrimal system.

As shown in my U.S. patent application Ser. No. 10/259,300 and publishedunder U.S. Pat. Pub. No. 20040064150, incorporated herein by thisreference, I teach that various balloon catheters can be used to treatparanasal sinuses in a number of ways. The catheters are used to dilatean existing ostium or duct, to create a new opening from a sinus to thenose, or to excise a sinus. However, blood, mucus or other material mayobscure visualization when using a sinus balloon catheter. Also, otherprocedures such as excision of nasal or sinus tissue, polyps, mucoceles,or removal of pus, manipulation of the nasal or sinus structures wouldnot be attempted using a balloon catheter because visualization and/ordelivery of medication would be problematic.

Endoscopes have long been commercially available to provide the surgeongreater visualization of internal patient tissues. Endoscopes typicallyhave a narrow, elongated body carrying fiber optic structures whichallow viewing from a proximal eyepiece to a distal viewing lens andcarry an illuminating; light from a proximal source to a distal emitter.Endoscopes can have bodies which are rigid such as the KARL STORZSINUSCOPE brand endoscope, or flexible such as the MACHIDA ENT SCOPEbrand endoscope commercially available from Karl Storz, of Culver City,Calif. and Jedmed Instrument Company, of St. Louis, Mo. respectively.Endoscopes are typically not intended to bend sharper than a minimumradius. Some endoscopes can attach to a camera which can be joined tothe endoscope at its proximal end. Some endoscopes have a viewing lensat the distal end which aims at an angle from the major axis of theendoscope body. This angle can range from 0 to 70 degrees. Many commonlyused rigid endoscopes have an angle of about 25 or 30 degrees.

It has been found that the use of endoscopes simultaneously withirrigation and suction systems can be overly bulky in the small confinesof some anatomical regions such as the nasal cavity or sinus. Further,using so many systems at once can leave the surgeon short handed.

Hand bending the balloon catheter body, though conveniently providingthe surgeon with greater flexibility during surgery to adapt thecatheter shape to the unique anatomy of the individual patient, can leadto additional problems. First, the catheter should remain sufficientlystiff to withstand the lateral or torsional forces required to push thedeflated balloon section through the small opening in the tissue.Second, the surgeon may accidentally bend the catheter body beyond amaximum allowable angle, or at such a sharp radius that a flowconstricting kink is created.

A review of the prior art shows a number of patents (Katz U.S. Pat. No.6,027,478; Brennan U.S. Pat. No. 4,883,465; Akiyama U.S. Pat. No.4,102,342; Payton U.S. Pat. No. 4,338,941; Katz U.S. Pat. No. 5,454,817;Stangerup U.S. Pat. No. 5,546,964 and Shippert U.S. Pat. No. 5,827,224)which teach the use of expandable devices (usually a balloon) into thenasal cavity or sinuses. Most of these are for the treatment of nosebleeds or the control of bleeding.

A number of articles disclose the use of a balloon catheter in sinusesto hold fractured bones in place, stop bleeding by tamponade, preventfluid from flowing out of the nose into the pharynx, or to maintain alow intranasal air pressure. In one case, a catheter was used to stent aduct after surgery; and the balloon was inflated in the sinus to keepthe stent in position.

However, apart from my prior application, there appear to be noteachings in the prior art to use a balloon catheter to create a newopening from a sinus into the nose, to dilate an ostium or duct, dilatethe choana or excise a sinus. It appears a balloon has never been usedto directly treat sinus disease.

SUMMARY

The present embodiments teach the use of sinus balloon catheters totreat sinus disease by creating a new opening from a sinus into thenose, to dilate a sinus ostium or duct, to dilate the choana or toexcise a sinus. A balloon is mounted over the distal segment of thecatheter to which runs a conduit permitting a pressurized fluid toinflate the balloon. The catheter is formed to have sufficient stiffnessand column strength to be pushed through a surgically prepared small,tight opening from a sinus into the nose, through a sinus ostium orduct, or the choana or into a sinus cavity. The small opening may becreated surgically or may be the natural ostium or duct of the sinus.

Some embodiments provide a catheter having integrated suction and/orirrigation systems that enable the surgeon to irrigate and/or suctionaway blood, mucus, pus, a mucocele and other material. The proximal endof the catheter has connectors to the various fluid supplies, suctionsources, and wings or other prominences to allow the surgeon easiermanipulation. The presence of suction and/or irrigation allows for theless obstructed use of an endoscope which greatly facilitates thesurgeon visualizing the balloon catheter and the patient tissues inperformance of the procedure.

Some embodiments provide a catheter having a conduit through which anendoscope can be inserted further reducing the bulkiness of the systems.Other embodiments provide an integrated endoscope in addition to theintegrated suction and/or irrigation systems.

Balloon catheters having integrated suction, irrigation and endoscopiccapability can be utilized to more efficiently and safely perform anumber of procedures in the nasal cavity and sinus.

Other embodiments provide a set of catheters having differentconfigurations and dimensions suitable for the treatment of differentparts of the paranasal sinus system.

In other embodiments the balloon catheter has a proximal segment and acircular bend placing a distal segment at an angle of about 60 degreesto 130 degrees. The angled distal segment allows the surgeon to rotateor shift the position of the long proximal catheter shaft, thuspositioning the distal segment to enter from the nasal cavity into thesinus at various angles appropriate to each individual patient. Acatheter having an angle of approximately 90 degrees can be used totreat maxillary and frontal sinus disease.

Another embodiment provides a balloon catheter which is straight or hasa minimal angle of about 0 to 60 degrees at the junction of the distalsegment and the proximal segment. This catheter is useful forethmoidectomy and sphenoid sinusotomy which uses a balloon with aninflated diameter of about 7 mm, or dilation of the choana and uses aballoon with an inflated diameter of about 9 mm.

Other embodiments provide balloon catheters having a sufficiently smalldeflated profile to fit through the sinus ostium, duct, or opening inthe nasal wall or scar tissue into the sinus.

Other embodiments provide methods to open or enlarge an obstructed ornarrowed ostium or duct of a sinus using a balloon and allow the sinusto drain into the nose. The methods also allow dilation and suction of astenotic or atretic choana. The methods enable irrigation and suction aspart of the sinus balloon catheters, and allow the use of an endoscopewith the balloon catheter. The irrigation, suction, and endoscopeprovide better visualization by the surgeon in spite of bleeding or thepresence of mucus or other debris. Such debris including pus or amucocele can be suctioned from the sinus. Medication can also beintroduced through the irrigation port. These procedures areaccomplished without causing damage to the surrounding structures suchas the optic nerve, extraocular muscles that move the eye, the orbit,brain, meninges, or nasolacrimal duct.

Other embodiments provide a method which removes a sinus and cures sinusdisease without damage to the surrounding structures such as the opticnerve, extraocular muscles, orbit, brain, meninges, and nasolacrimalduct. These methods are useful for opening a sinus ostium or duct whichhas been narrowed or obstructed by scar tissue from previous surgery ortrauma, for creating a new opening in the wall of a sinus which has scartissue to allow proper drainage of the sinus into the nose, and forremoving a sinus which has scar tissue.

Other embodiments provide methods including a balloon catheterantrostomy of the maxillary ostium, a balloon catheter middle meatalmaxillary antrostomy, a balloon catheter inferior meatal antrostomy, aballoon catheter ethmoidectomy of the anterior ethmoid sinus, a ballooncatheter ethmoidectomy of the posterior ethmoid sinus, a ballooncatheter sinusotomy of the sphenoid sinus, a balloon catheter frontalsinusotomy, and balloon catheter dilation of the choana. These methodsare improved by the greater visualization provided by an endoscopeunobstructed by irrigatably suctionable debris.

In some embodiment there is provided a catheter for dilating a space ina patient, said catheter comprises: an oblong body having a proximalsegment and a distal segment; a balloon member secured to said distalsegment; a first conduit in fluid communication with said balloon,whereby fluid under a given pressure in said first conduit inflates saidballoon; and, a second conduit having a distal port outside saidballoon.

In some embodiments, said conduit is adapted to provide suction at saidport. In some embodiments, said conduit is adapted to provide irrigationat said port. In some embodiments, said first and second conduits areformed into a multi-channel fluid buss extending between said proximaland distal segments. In some embodiments said first conduit terminatesat a first conduit opening inside said balloon. In some embodiments saidballoon has a substantially barbell shape when inflated. In someembodiments said second conduit has a distal terminus at said port andwherein said port is located a first distance from a distal neck of saidballoon. In some embodiments said balloon annularly surrounds a portionof said second conduit. In some embodiments the catheter furthercomprises a third conduit having a distal port outside said balloon. Insome embodiments said second conduit and said third conduit are coaxial.In some embodiments said second conduit and said third conduit arenon-coaxial. In some embodiments the catheter has a stiffness whichrenders it hand bendable. In some embodiments the catheter has astiffness which renders it non-hand bendable. In some embodiments saidcatheter has a bend. In some embodiments said balloon has a proximalneck extending over said bend. In some embodiments said body furthercomprises axial gradation markings. In some embodiments said secondconduit has an inner diameter selected to allow passage of an endoscopetherethrough. In some embodiments the catheter further comprises meansfor angularly securing said endoscope to said catheter. In someembodiments said means comprise at least one projection extendingradially from a section of said endoscope. In some embodiments saidcatheter further comprises an angular orientation indicator. In someembodiments said second conduit is shaped to have an angular cutawayforming said port. In some embodiments said second conduit is formed ofa stainless steel hypotube with a wall thickness of at least 0.010″. Insome embodiments said distal segment is at an angle of between about 0degrees and about 130 degrees to said proximal segment. In someembodiments said distal segment is at an angle of between about 0degrees and about 90 degrees to said proximal segment. In someembodiments said distal segment is at an angle of about 0 degrees tosaid proximal segment, whereby said catheter body is straight.

In some embodiments, there is provided a kit for use in the treatment ofa patient's nasal sinuses, said kit comprises: a first balloon catheterhaving an oblong body; and, a catheter bending tool having a given bendradius and a first surface shaped and dimensioned to intimately contactand bear against a portion of said body. In some embodiments said givenbend radius is at least 0.5 centimeter. In some embodiments said kitfurther comprises an endoscope having a minimum bend radius which isgreater than said given bend radius of said tool.

In some embodiments, it is provided that in a sinus balloon catheterdevice comprising proximal and distal sections, a balloon mounted tosaid distal section, and a first conduit for inflating said balloon, animprovement which comprises a second conduit having a distal portoutside said balloon.

In some embodiments, there is provided a balloon catheter for dilating aspace in a patient's nasal sinus system, which is one of a preparedopening, an ostium or duct, or a sinus cavity to be excised, or choana,comprising: a tubular catheter body having a proximal end, a proximalsegment, a distal end, and a distal segment; a balloon member disposedabout said distal segment, said distal segment having a slot; saidcatheter body being closed at a point distally of said slot; means forapplying fluid under pressure to said proximal end of said catheterbody, said fluid under pressure flowing through said slot to inflatesaid balloon for dilating said space; and said catheter body beingformed of a hypotube of sufficient stiffness and column strength toenable said catheter, when said inflatable member is deflated, to bepushed into said space of said nasal sinus system.

In yet other embodiments there is provided a method of treating apatient's nasal sinuses, comprising: providing a balloon catheter havingan oblong body having a proximal segment, a distal segment, and a firstinflation/deflation supply conduit in fluid communication with a balloonmounted on said distal segment; pushing said distal segment with saidballoon deflated into a space associated with a nasal sinus of saidpatient; and introducing fluid under pressure into said supply conduitto inflate said balloon and dilate said space.

In some embodiments said balloon catheter further comprises a secondconduit. In some embodiments the method further comprises suctioningdebris from said nasal sinus through said second conduit. In someembodiments the method further comprises irrigating said nasal sinusthrough said second conduit. In some embodiments the method furthercomprises irrigating said nasal sinus through said second conduit at atime when said suctioning is not occurring. In some embodiments themethod further comprises bending said body to an angle of between about0 degrees and 130 degrees prior to said pushing. In some embodiments themethod further comprises inserting an endoscope through said secondconduit. In some embodiments said balloon catheter further comprises athird conduit, and wherein said method further comprises: suctioningdebris from said nasal sinus through said second conduit; and,irrigating said nasal sinus through said third conduit. In someembodiments said body is flexible, and said method further comprisesthreading said body onto a rigidizing member having sufficient stiffnessand column strength to enable said catheter, when said balloon isdeflated, to be pushed into said space of said nasal sinus system. Insome embodiments said tubular catheter body has a bend placing saiddistal segment at an angle of between about 60 degrees and about 130degrees to said proximal segment. In some embodiments said angle isabout 90 degrees.

In some embodiments of the method said space is the maxillary ostium ofthe patient's maxillary sinus, said distal segment with said balloondeflated being pushed through said maxillary ostium into said maxillarysinus, said maxillary ostium being dilated when said inflatable memberis inflated to complete antrostomy of said maxillary ostium. In someembodiments, prior to said step of pushing said distal segment throughsaid maxillary ostium, said method further comprises: mediallyretracting the patient's middle turbinate to gain access to thepatient's middle meatus; and, exposing the patient's ethmoidinfundibulum by removing part of the patient's uncinate process.

In some embodiments, said space is a prepared opening formed through thepatient's fontanelle, said opening is formed by bringing a 45 degreeupbiting Blakesely punch into the patient's nasal cavity along thepatient's lateral nasal wall just superior to the patient's inferiorturbinate, pushing said punch through said fontanelle to create saidopening through said fontanelle and wherein said distal segment withsaid balloon deflated is pushed into said prepared opening and saidballoon is inflated to dilate said prepared opening.

In some embodiments, said space is a prepared opening formed through thepatient's lateral nasal wall in the patient's inferior meatus. In someembodiments, prior to said step of pushing, said prepared opening isformed by displacing the patient's inferior turbinate medially,introducing a sharp dissector into the patient's nasal cavity, and usingsaid dissector to perforate the patient's lateral nasal wall in saidinferior meatus to form said opening and wherein said distal segmentwith said balloon deflated is pushed into said prepared opening and saidballoon is inflated to dilate said prepared opening. In someembodiments, said distal segment is positioned at an angle of betweenabout 0 degrees and about 60 degrees to said proximal segment. In someembodiments, said distal segment is at an angle of about 0 degrees tosaid proximal segment, whereby said catheter body is substantiallystraight.

In some embodiments, said space is formed in the patient's ethmoidbulla. In some embodiments, the method further comprises: mediallyretracting the patient's middle turbinate to gain access to thepatient's middle meatus; exposing the patient's ethmoid infundibulum byremoving part of the patient's uncinate process; and, using a finecutting forceps to remove the anterior wall of said ethmoid bulla. Insome embodiments, after said inflatable member is deflated and withdrawnfrom said ethmoid bulla, providing said opening in said ethmoid bulla toreceive said distal segment, which when inflated, dilates and therebyremoves said ethmoid bulla. In some embodiments, said inflated balloonis then deflated and said distal segment is then withdrawn from thespace formerly occupied by said ethmoid bulla, said distal segment withsaid balloon deflated is then pushed into the patient's anterior ethmoidair cells, forming the patient's ethmoid sinus, lying posterior to saidspace formerly occupied by said ethmoid bulla, said balloon is theninflated dilating said anterior ethmoid air cells and thereby removingsaid anterior ethmoid air cells, and said balloon is then deflated, andsaid distal segment is then removed from the space formerly occupied bysaid anterior ethmoid air cells, completing an ethmoidectomy of theanterior ethmoid sinus. In some embodiments, the patient's basal lamellaof the patient's middle turbinate is perforated with a punch to form anopening, said distal segment is then pushed through said opening intosaid posterior ethmoid air cells and said balloon is inflated to dilateand remove said posterior ethmoid cells completing an ethmoidectomy ofsaid posterior ethmoid sinus. In some embodiments, after said anteriorand posterior ethmoidectomies are completed, inserting said distalsegment through the patient's anterior wall of the patient's sphenoidsinus, the balloon is then inflated for dilation and opening of saidsphenoid sinus, the deflating said balloon and removing said distalsegment to complete sinusotomy of said sphenoid sinus.

In some embodiments, said space is an opening through the patient'santerior wall of the patient's sphenoid sinus; and wherein said methodfurther comprises deflating said balloon and removing said distalsegment to complete sinusotomy of said sphenoid sinus.

In some embodiments, said space is the patient's nasofrontal duct to thepatient's frontal sinus; and wherein said method further comprisesdeflating said balloon and removing said distal segment to completesinusotomy of said frontal sinus.

In some embodiments, after said ethmoidectomy of said anterior ethmoidsinus is completed and the patient's nasofrontal duct is exposed,providing a second balloon catheter having a tubular catheter body witha proximal segment, a distal segment, a balloon member mounted aroundsaid distal segment, a slot through the wall of said distal segment,said tubular body being closed at a point distally of said slot, andmeans providing fluid under pressure at the proximal end of said tubularcatheter body to inflate said balloon, said tubular catheter body havinga bend placing said distal segment at an angle of between about 60degrees and about 130 degrees to said proximal segment, pushing saiddistal segment of said second balloon catheter with said balloon of saidsecond balloon catheter deflated into said frontonasal duct, inflatingsecond balloon catheter to dilate said frontonasal duct and frontalsinus, deflating said balloon of said second balloon catheter, andremoving said distal segment of said second balloon catheter to completea frontal sinusotomy.

In some embodiments, said space is a choana, said distal segment withsaid balloon deflated being pushed into the choana, said choana beingdilated when said inflatable member is inflated.

In some embodiments, there is provided an apparatus for treatingprepared openings and natural ostia or ducts providing flow paths fromnatural sinus cavities, and excising sinus cavities, comprising: a setof balloon catheters including catheters which are angled and catheterswhich are substantially straight, said catheters having appropriateinflated working diameters, and which have appropriate outer diameterswith the balloon deflated that will enable the catheter in question tobe pushed into the respective prepared opening, natural ostium or ductor sinus cavity to be excised.

BRIEF DESCRIPTION OF THE DRAWING

FIG. 1A is a diagrammatic perspective view of a suctioning andirrigating balloon catheter.

FIG. 1B is a closeup diagrammatic cross-section view of the tip of thedistal segment of the suctioning and irrigating balloon catheter of FIG.1A.

FIG. 1C is a closeup diagrammatic cross-section view of the proximal endsegment of the suctioning and irrigating balloon catheter of FIG. 1A.

FIG. 2A is a closeup partial side elevational view and partialcross-sectional side view of the proximal and distal end segments of thesuctioning and irrigating balloon catheter according to an alternateembodiment.

FIG. 2B is a closeup diagrammatic partial perspective view of theproximal end of a suctioning and irrigating balloon catheter accordingto another alternate embodiment.

FIG. 2C is a closeup diagrammatic cross-sectional side view of theproximal end of a multi-conduit balloon catheter according to anotheralternate embodiment providing either suctioning or irrigating at onetime.

FIG. 2D is a closeup diagrammatic cross-sectional side view of theproximal and distal ends of a multi-conduit balloon catheter having aninternal inflation/deflation conduit according to another alternateembodiment.

FIG. 2E is a diagrammatic cross-sectional end view of the amulti-conduit balloon catheter body having a flattened internalinflation/deflation conduit according to another alternate embodiment.

FIG. 3A is a diagrammatic elevational view of a suctioning andirrigating catheter having a distal bend.

FIG. 3B is a diagrammatic partial side elevational view of thesuctioning and irrigating balloon catheter being bent with a givenradius.

FIG. 3C is a diagrammatic perspective view of a tool for bending acatheter according to a given radius.

FIG. 3D is a closeup diagrammatic cross-section view of the distal endsegment of the suctioning and irrigating balloon catheter according toanother alternate embodiment having a pinched center balloon.

FIG. 3E is a diagrammatic perspective view of a flexible bodymulti-conduit balloon catheter according to another alternateembodiment.

FIG. 3F-FIG. 3I are diagrammatic side elevational view of differentlyangled rigidizing members for providing rigidity to the catheter of FIG.3E.

FIG. 4 is a schematic drawing of a step of a method, showing theuncinate process being removed with a punch to expose the ethmoidinfundibulum and semilunar hiatus.

FIG. 5 is a schematic drawing of another step of the method of FIG. 4showing the sinus balloon catheter dilating and thereby enlarging theostium of the maxillary sinus and performing suction and irrigationfunctions.

FIG. 6 is a schematic drawing of a step of a second method showing theBlakesely punch creating a small opening in the fontanelle of thelateral nasal wall in the middle meatus thus creating a communicationbetween the maxillary sinus and nasal cavity.

FIG. 7 is a schematic drawing of another step of the method of FIG. 6showing the sinus balloon catheter dilating the opening in thefontanelle of the lateral nasal wall in the middle meatus thus creatinga large communication opening (antrostomy) for drainage from themaxillary sinus into the nasal cavity and performing suction andirrigation functions.

FIG. 8 is a schematic drawing of a step of a third method showing thedissector perforating the lateral nasal wall in the inferior meatus intothe maxillary sinus.

FIG. 9 is a schematic drawing of another step of the method of FIG. 8showing the sinus balloon catheter dilating the opening in the lateralnasal wall in the inferior meatus thus creating a large antrostomy fordrainage from the maxillary sinus into the nasal cavity and performingsuction and irrigation functions.

FIG. 10 is a schematic view of a fourth method showing the cuttingforceps making a new opening in the anterior wall of the ethmoid bulla.

FIG. 11 is a schematic view of another step of the method of FIG. 10showing the straight sinus balloon catheter dilating the ethmoid bullaand performing suction and irrigation functions.

FIG. 12 is a schematic view of yet another step of the method of FIG. 10showing the straight sinus balloon catheter dilating the ethmoid aircells and thus completing the anterior ethmoidectomy and performingsuction and irrigation functions.

FIG. 13 is a schematic view of yet another step of the method of FIG. 10showing a punch perforating the basal lamella of the middle turbinate.

FIG. 14 is a schematic view of still another step of the method of FIG.10 showing the straight sinus balloon catheter dilating the posteriorethmoid air cells and thus completing the posterior ethmoidectomy andperforming suction and irrigation functions.

FIG. 15 is a schematic view of an additional step of the method of FIG.10 showing the sinus balloon catheter dilating the anterior wall of thesphenoid sinus and performing suction and irrigation functions.

FIG. 16 if a schematic view of a further step of the method of FIG. 10showing the angled sinus balloon catheter dilating the frontonasal ductand performing suction and irrigation functions.

FIG. 17 is a schematic drawing of a step of a method showing thesuctioning and irrigating balloon catheter dilating the choana andperforming suction and irrigation functions.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring now to the drawing there is shown in FIGS. 1A-1C, a firstembodiment of a suctioning and irrigating sinus balloon catheter 301having a generally oblong body 302 having a proximal segment 303, aproximal end 304, a distal segment 305 and a distal end 306. Aninflatable balloon 307 is located on the distal segment of the body nearthe distal end.

The catheter body 302 has a given axial length as measured from proximalend to distal end or tip which is selected according the anatomy of thepatient. For most human patients the length is preferably between about1 inch and about 20 inches, and most typically between about 5.5 inchesand about 6.5 inches. A number of specific length catheters can be madeavailable as part of a kit so that the surgeon has a choice for a givensituation. For example, a kit can contain six differently sizedcatheters ranging from 5 inches to 10 inches at 1 inch increments.

The balloon 307 is preferably formed from a highly resilient durablebiocompatible material such as polyethylene terephthalate. It has agenerally ellipsoidal shape when inflated and a generally cylindricalshape closely corresponding with the outer surface 308 of the distalsegment 305 of the body 302 when deflated. The inflated diameter isselectable by the surgeon to be between the deflated diameter and aworking inflated diameter of between about 2 mm to about 15 mm,typically about 7 mm, for use in the sinus system, except for use in thenasofrontal duct where the inflated working diameter is typically about5 mm. The balloon has an axial length selected according the anatomy ofthe patient and the procedure being performed. For most uses a range ofbetween about 2 mm and about 40 mm is preferred. Most typically thelength can be about 14 mm.

A number of specific length balloons can be made available as part of akit so that the surgeon has a choice for a given situation. For example,a kit can contain six differently sized balloons ranging from 3 mm to15.5 mm at 2.5 mm increments. Alternately, a kit may contain balloonshaving different diameters from about 3 to 13 mm at 2.5 mm increments.

FIG. 1B shows that the balloon 307 has a distal neck 310, a distaltapered region 311, a center region 312, a proximal tapered region 313,and a proximal neck 314 and defines an internal chamber or inside 316 ofthe balloon. A layer of adhesive 315, such as cyanoacrylate, is used tobond the necks to the outer surface 308 of the body of the catheter.

The body comprises a plurality of conduits 320, 321, 322 to carry fluidsto and from more distally located portions of the catheter. A pluralityof conduits running through or bundled to form the body can be said toprovide a multi-channel fluid buss through the catheter.

In most embodiments, the catheter should have sufficient stiffness andcolumn strength with marked resistance to lateral bending that itsdistal segment carrying the deflated balloon can be used in the surgicalmethods described below, such as being pushed through a prepared small,tight opening from a sinus into the nose, pushed through a sinus ostiumor duct, or pushed into a sinus cavity which may require considerablepressure in some cases. This required stiffness can be supplied by oneor more of the conduits being formed from a rigid durable material suchas stainless steel.

In the present embodiment the body has a pair of coaxial tubes 325,326,each having an opening or port 330,331 at the distal end 306 which isoutside of the balloon and is located an axial distance D₁, D₂ from thedistal neck 310 of the balloon 307. That distance is preferably betweenabout 0 mm and about 5 mm, and is typically about 1 mm. The firstexternal tube 325, is made from a rigid or semi-rigid durable materialsuch as stainless steel, titanium and preferably supplies an irrigatingfluid. The external irrigation tube preferably has an outer diameterwhich measures between about 0.05 inch and about 0.7 inch, and mosttypically about 0.095 inch. The inner diameter is preferably betweenabout 0.020 inch and about 0.6 inch, and most typically about 0.071inch.

The second, internal tube 326 runs through the central lumen of theexternal tube 325, thereby forming an annular conduit 322 between thetubes. The internal tube has its own central lumen which defines asecond conduit 321 of the catheter which preferably provides suction.The internal tube can be made from thinner stainless steel or a moreflexible material such as silicone or polyethylene. Care should be takento select a material which has sufficient rigidity to prevent itscollapse under the vacuum forces acting on the suctioned fluid. Theinternal suction conduit terminates at a nozzle 331 at the distal end306 of the catheter. The irrigation conduit similarly terminates at thedistal end forming an annular nozzle 330. The suction tube 326 has anouter diameter smaller than the inner diameter of the irrigation tube325. The suction tube preferably has an outer diameter which measuresbetween about 0.019 inch and about 0.59 inch, and most typically about0.065 inch. The inner diameter is preferably between about 0.010 inchand about 0.58 inch, and most typically about 0.056 inch.

Referring now to FIGS. 1A and 1C, the proximal end 334 of the suctiontube 326 extends a distance from the proximal end 335 of the irrigationtube 325 and terminates at a connector 336 allowing unobstructedconnection to the suction source. The distance is preferably betweenabout 0.5 centimeter (“cm”) and about 5 cm, and most typically about 1cm.

A third tube 340 is provided as a balloon inflation/deflation supplyconduit, and extends substantially along the length of the body 302 andtangentially contacts the outer surface 337 of the first tube 325. It ismade from thin stainless steel, flexible silicone, polyethylene or otherdurable, biocompatible material and has a central lumen defining a thirdconduit 320 of the catheter which terminates at an opening 339 insidethe balloon. The third tube is preferably bonded to the first externaltube by welding or an adhesive. This balloon supply conduit suppliesfluid for filling and evacuating the balloon and is therefore in fluidcommunication with the inside 316 of the balloon. The inner diameter ispreferably between about 0.005 inch and about 0.13 inch, and mosttypically about 0.020 inch. The outer diameter is preferably betweenabout 0.015 inch and about 0.15 inch, and most typically about 0.028inch. The proximal end 341 of the inflation/deflation supply tube 340extends at an angle from the external irrigation tube and terminates ata connector allowing unobstructed connection to the ballooninflation/deflation fluid supply source. Alternately, the supply tubecan remain straight and terminate at its proximal end luer lockconnector a distance from the proximal end of the irrigation tube. Thedistance is preferably between about 1 millimeter (“mm”) and about 10cm, and most typically about 2 cm. The third inflation/deflation supplytube also extends at an angle away from the outer surface of theexternal tube which allows unobstructed connection to the ballooninflation/deflation supply.

Optionally, as shown in FIG. 1A, the catheter body may have axialgradations or other markings 309 which allow it to act as an axialmeasuring device to help ascertain or verify patient anatomy andlocation of the balloon.

Referring now to FIG. 1C, the proximal end 304 of the catheter 301 isformed to have connectors for each of the conduits. A first connector336 on the suction conduit 321 can have wings 343 or other enlargementor expansion which are graspable by the surgeon to manipulate thecatheter. The inner diameter of the connector 336 matches the externaldiameter of the suction hypotube 326 forming the suction conduit 321.

To supply the irrigation conduit 322, a small tube 344 extends at anangle through the sidewall of the irrigation conduit tube 325 andterminates in a connector 345 which connects to the irrigation sources.The length is preferably between about 1 millimeter (“mm”) and about 50mm, and most typically about 12 mm. The angle is preferably betweenabout 1 degree and about 175 degree, and most typically about 45 degree.The inner diameter of the supply tube is preferably between about 0.010inch and about 0.4 inch, and most typically about 0.070 inch. The outerdiameter is preferably between about 0.020 inch and about 0.5 inch, andmost typically about 0.083 inch.

A stopper 347 made from a resilient fluid impermeable material such asrubber seals the proximal end 335 of the external tube 325. The stopperhas a central channel which allows passage of the suction tube 326therethrough. The stopper may be sealed permanently using glue or otheradhesive means or can be pressure fitted.

Because it is generally more important for the surgeon to more preciselycontrol the location of the suction nozzle, the internal tube is usedfor suction. However, it is possible for the function of the first twoconduits to be swapped.

Referring now to FIG. 2A, there is shown an alternate embodiment of thesuctioning and irrigating balloon catheter 350 having a first conduit351 for carrying irrigation fluid, a second conduit 352 running alongside the first conduit which provides suction and a third conduit 353running along side the first conduit which inflates/deflates theballoon.

The irrigation conduit is fitted with hand manipulable wings 354 at itproximal end 355. The suction conduit is preferrably made from a durablerigid or semi-rigid material such as stainless steel or polyethylene.The inner diameter is preferably between about 0.012 inch and about 0.35inch, and most typically about 0.05 inch. The outer diameter ispreferably between about 0.025 inch and about 0.5 inch, and mosttypically about 0.065 inch.

The irrigation conduit can be utilized to carry an oblong endoscope 360therethrough. The endoscope enables the surgeon to visualize the sinuscavity and associated structures.

Since many endoscopes have an angled view head 361 which can typicallybe at an angle of 30 degrees off the major axis of the endoscope, thisembodiment provides a nozzle 362 at the distal end opening of the firstirrigating conduit which has a cutaway 363 so as to not obscure the viewfrom the distal tip of the endoscope. Further, in order to maintain theproper angular orientation of the endoscope head 366 with respect to thecutaway, an angularly keyed engagement 367 is provided at the proximalend of the catheter. In this way an endoscope having a correspondinglykeyed haft in the form of a radial projection 368 will engage theengagement on a unique and appropriate angular orientation, therebyangularly securing the endoscope to the catheter. The radial projectionalso acts as an indicator of the angular orientation of the endoscopeand catheter.

FIG. 2B shows that the above embodiment can be adapted to provide anintegrated endoscope 370 which is carried inside the first conduit 371.An external hypotube is selected to have an inner diameter which allowspassage of an endoscope and provide enough space to form an annularconduit for carrying irrigation fluid. The inner diameter is preferablybetween about 0.02 inch and about 0.5 inch, and most typically about 0.1inch. The outer diameter is preferably between about 0.03 inch and about0.6 inch, and most typically about 0.134 inch.

A supply port 375 is provided to supply irrigating fluid which flowsthrough the annular channel formed between the cylindrical outer surfaceof the endoscope 370 and the cylindrical inner surface of the firstconduit 371. A stopper 376 prevents fluid from exiting the proximal endof the first conduit. A suction conduit 377 and balloon supply conduit378 are formed onto the catheter body along side of the first conduit.Alternately, an additional suction port 380 is provided on the catheterbody proximal to the balloon 381. The additional port is formed by ahole through the side wall of the suction conduit 377. In addition,irrigation proximal to the emplaced balloon can be provided byadditional irrigation nozzles formed by one or more holes 385 throughthe outer hypotube wall of the irrigation conduit 371. Care should betaken to size the holes so that adequate suction and irrigation isprovided at the distal terminus of the suction and irrigation conduits.Removable plugs 386 can be provided to seal off the additional holeswhen their use is not desired.

As shown in FIG. 2C a multi-conduit balloon catheter 387 is providedhaving a first conduit 388 and a side-mounted inflation/deflationconduit 389. The first conduit can be used either for suctioning orirrigating, and can even be switched between suctioning and irrigatingin-situ. Further, an endoscope can be inserted through the conduit.

As shown in FIG. 2D, a multi-conduit balloon catheter 390 can have afirst conduit 391 and a second, balloon inflation/deflation conduit 392mounted internally within the first conduit. One way to allow theinternal inflation/deflation conduit to be in fluid communication withthe inside 393 of the balloon 394 is to provide a slot 395 extendingthrough the side walls of the first an second conduit on a portion 396of the catheter covered by the balloon. It should be noted that anengagement tube 397 is used for fluid communication with the inside ofthe first conduit. The first conduit can either be used for suction orirrigation and can be switched between the two in-situ.

As shown in FIG. 2E, the internal balloon inflation/deflation conduit398 can be made to have a cross-section which is not circular, butrather is flattened in a generally rounded sickle shape in order toaccommodate an endoscope 399 having a larger diameter D than would beavailable if the inflation/deflation conduit had a circularcross-section. In this way, the first conduit 399 b can be kept smallwhile still accommodating a larger diameter endoscope.

As shown in FIG. 3A the catheter can be formed to have a bend 400 toallow more convenient and proper placement of the balloon duringsurgical procedures. The angle A formed by the bend is selectedaccording the anatomy of the patient and the procedure being performed.Typically, the angle will be between 0 degrees (completely straight) and130 degrees. There is a bend having a given radius which is preferablybetween about 0.05 inch and about 3 inches, and typically about 0.13inch, and can be formed such that distal segment 137 is oriented 60degrees to 130 degrees, preferably 90 degrees, to proximal segment 139.The axial distance D_(B) from the distal tip 184 of distal segment 137to the outer wall of proximal segment 139 of outer tube of the catheter136 is 4 mm to 30 mm, preferably 14 mm. The proximal neck 178 may bebonded on distal segment 137 of tube 136 or extend over bend 138 ontothe distal end portion of proximal segment 139 of tube 136. Extension ofthe proximal neck 178 onto bend 138 and proximal segment 139 allows agreater length of the working diameter, i.e., center region 174, to beon distal segment 137 of tube 136.

The length of the distal segment is short enough to allow it to berotated within the nasal cavity and thus enter from the nasal cavityinto the sinus at the desired angle. The distal segment is long enoughto allow a balloon of sufficient length and diameter to be attached fordilation of an opening through the lateral nasal and sinus wall, duct,ostium or choana. The balloon material is attached with adhesive to thevery distal portion of the distal segment and to the proximal portion ofthe distal segment, the bend, and the very distal portion of theproximal segment. A longer working segment of balloon can be usedbecause the area of adhesion of the balloon includes the bend and thedistal portion of the proximal segment. A 7 mm inflated diameter angledballoon is used to treat the maxillary sinus and a 5 mm inflateddiameter angled balloon is to treat the frontal sinus. The balloondiameter can vary from about 2 to 20 mm in diameter.

The catheter is formed to have sufficient stiffness and column strengthto be pushed through a surgically prepared small, tight opening from thesinus into the nose, through a sinus or osteum or duct, or into a sinuscavity, or into the choana. Therefore, at least one of the tubes, andpreferably the largest outer tube is formed from a hypotube of stainlesssteel or other rigid or semi-rigid, durable, biocompatible material.However, it can also be advantageous to form the catheter such that ithas a stiffness which allows it to be hand bent by the surgeon prior toor even during surgery. This stiffness tradeoff can lead to a catheterwhich is difficult to bend properly so as not to create kinks in one ormore of the conduits, and which is essentially hand unbendable. A typeof steel having a higher malleability can be used which can allowsharper bending without kinking. In addition, most commerciallyavailable flexible endoscopes are not intended to be bent further than aminimum radius. In other words, bends in the flexible body of theendoscope should not be sharper than a minimum radius. Therefore, asshown in FIG. 3B, the surgeon should take care not to bend the bendablecatheter to have a curve sharper than a given radius R.

As shown in FIG. 3C, as part of the kit, the surgeon is provided with amanual bending tool 500 similar to a pipe bending tool used by plumbers.The tool has a rigid, arcuate contact plate 501 in a generally half-pipeshape having a lateral diameter D which is commensurate with the outersurface diameter of the catheter body. This provides the tool with afirst surface which can intimately contact and bear against a portion ofthe catheter body proximate to the axial location of the intended bend.The plate is also curved longitudinally to have a given radius R. Areleasably adjustable strap 502 is provided for temporarily fastening aportion of the catheter body to the tool. The strap has a number ofbutton holes 503 for engaging a button 504 on the tool to accommodate arange of catheter body outer diameters. A handle 505 provides for manualcontrol of the tool by the surgeon. In this way the surgeon canprecisely shape the catheter, even during surgery if necessary, to haveone or more bends of a given bend radius R. If a flexible endoscope isto be treaded through the catheter, the given bend radius should begreater than or equal to the minimum bend radius of the endoscope. Formany applications the preferred bend radius is at least 0.5 centimeter.Further, tools having different radiuses can be supplied in the kit.Further the surgeon can form bends outside the plane of prior bends,thereby making a custom three dimensional rigid catheter for a givenpatient and procedure.

Referring now to FIG. 3D, there is shown an alternate embodiment of thesuctioning and irrigating catheter 430 having a balloon 431 which, wheninflated, has a diameter in a medial section D_(M) which is smaller thanthe diameter on adjacent proximal D_(P) and distal sections D_(D). Thisallows the tissue/balloon interface to have greater axial stabilityduring inflation. The substantially barbell shaped balloon can be formeda number of ways. The preferred approach provides an axially medialsection of the balloon having a relatively greater thickness T_(M) thanthe thickness of adjacent proximal T_(P) and distal T_(D) sections. Thethickness of the proximal and distal sections is preferably betweenabout 0.0001 inch and about 0.1 inch, and most typically about 0.002inch. The thickness of the medial section is preferably between about0.0001 inch and about 0.1 inch, and most typically about 0.004 inch.

Referring now to FIGS. 3E and 3F, there is shown an alternate embodimentof the suctioning and irrigating catheter 530 having a balloon 531mounted upon the distal end segment 532 of a body 533 made from adurable, biocompatible, flexible material such as polyethylene or highmalleability steel. The catheter has a first, inflation/deflation supplytube 534 for operating the balloon, and a second, suctioning tube 535terminating at a distal suctioning port 536 located distally from theballoon. The flexible body catheter also has a third tube 537 shaped anddimension to be fitted as a sheath over an oblong, rigid, rod-like,rigidizing member 538 having a blunted distal end 539. The sheath has anopen proximal end 540 and a constricted, small diameter opening ornozzle 541 at a distal end 543 and a central lumen having an innerdiameter slightly larger than the outer diameter 542 of the rigidizingmember. Once the body is fitted over the rigidizing member, the catheterhas sufficient stiffness and column strength to allow it to be pushedinto the intended space in the patient. Once emplaced and the rigidizingmember can be withdrawn leaving the flexible body to more comfortablyconform to the patients internal anatomy.

It should be noted that the nozzle 541 is sized to prevent passage ofthe rigidizing member therethrough but does allow the sheath to also actas a fluid conduit for irrigation and/or suctioning purposes once therigidizing member is removed. Alternately, the distal end 543 of thesheath can be completely sealed off. Alternately, the rigidizing membercan be hollow such as in the form of a hypotube, or otherwise shaped toallow for passage of fluid through the open distal ended sheath whilethe rigidizing member is inserted.

Referring now to FIGS. 3G-3I, there are shown differently shapedrigidizing members. In FIG. 3G the rigidizing member 550 is shaped tohave a bend 551 which orients a distal portion 552 at an angle A_(R) toa proximal portion 553 of the member proximal to the bend. The member inFIG. 3F shows an angle A_(R) of about 0 degrees. The member in FIG. 3Gshows an angle A_(R) of about 60 degrees. The member in FIG. 3H shows anangle A_(R) of about 90 degrees. The member in FIG. 3I shows an angleA_(R) of about 130 degrees.

As will be described below, an angled suctioning and irrigating catheter130 and a “straight” suctioning and irrigating catheter 230 can be usedin different method steps for treating various prepared openings,naturally occurring ostia and ducts, choana, and sinus cavities.Depending on the size of the anatomical structures and the procedurebeing performed, the surgeon may also decide whether to utilize asuctioning and irrigating balloon catheter having an integratedendoscope. It is also to be noted that dimensions of the catheters areselected to accommodate different conditions in the paranasal sinussystem. For example, the outer diameters of the distal segments with theballoon deflated are selected so that the respective distal segmentswith the balloon deflated will fit snugly with the prepared openings,natural ostia or ducts, choana and sinus cavities into which thesedistal segments are to be pushed. As already mentioned, the workinginflated diameters of the balloons differ depending on the size requiredto treat different parts of the paranasal sinus system. Accordingly, thesurgeon can, at the time surgery is begun, have available a set of sinusballoon catheters which are angled or straight, the balloons of whichhave appropriate inflated working diameters, and which have appropriateouter diameters with the balloon deflated that will enable the catheterin question to be pushed into the respective prepared opening, naturalostium or duct or sinus cavity to be excised.

It is also useful to apply a lubricious coating to the balloon materialto facilitate pushing it through the lateral nasal wall and sinus wallinto the sinus.

Turning to FIGS. 4 and 5, in a method of performing balloon catheterantrostomy of the maxillary ostium, the middle turbinate 20 is retractedmedially to gain access to the middle meatus 22. In some cases themiddle turbinate is resected. The ethmoid infundibulum 24 is exposed byusing cutting forceps 67 to remove part of the uncinate process 26 (FIG.4). Distal segment 137 of balloon catheter 130 is then pushed throughthe maxillary ostium 41 (which is in ethmoid infundibulum 24) into themaxillary sinus 21. In some cases however, the maxillary ostium can beentered by the balloon catheter without removal of the uncinate process.As seen in FIG. 5, balloon 134 is inflated to between about 1 and 17bars, and most typically about 9 bars (atmospheres) for between about 1second and 20 minutes, and most typically about 20 seconds thendeflated. Distal segment 137 of balloon catheter 130 is slightlyrepositioned to insure full dilation and inflated again to 9 bars for 20seconds. Balloon 134 is then deflated, and catheter 130 is removed fromthe now enlarged ostium 41. The irrigation and suction functions of thecatheter are used to irrigate off and suction away blood, pus and otherdebris from the surrounding tissues, while the endoscope functionprovides good visualization for the surgeon. In this way the surgeondoes not need to hold a separate suction catheter and an irrigatingcannula in addition to the endoscope.

Turning to FIGS. 6 and 7, in a method of performing a middle meatalmaxillary antrostomy, an initial opening is made in the fontanelle 40(section of thin membranous tissue without bone of the medial maxillarysinus wall 42 which is also a portion of the lateral nasal wall 44).This is performed by bringing a 45 degree upbiting Blakesely punch 60into nasal cavity 38 along the lateral nasal wall 44 just superior tothe inferior turbinate 46 at the midpoint of its horizontal axis toperforate fontanelle 40 to create a new 3 mm opening 50 (FIG. 6). Thepunch 60 is removed, and sinus balloon catheter 130 is brought intonasal cavity 38 and pushed into the new opening 50 in fontanelle 40 oflateral nasal wall 44 (FIG. 7). Balloon 134 is inflated to 9 bars for 20seconds then deflated. Balloon catheter 130 is slightly repositioned inthe enlarged opening 50 to insure thorough dilation and inflated againto 9 bars for 20 seconds. Balloon catheter 130 is then deflated andwithdrawn from opening 50 and nasal cavity 38. The irrigation andsuction functions of the catheter are used to irrigate off and suctionaway blood, pus and other debris from the surrounding tissues, while theendoscope function provides good visualization for the surgeon.

As seen in FIGS. 8 and 9, in a method of inferior meatal antrostomy, theinferior turbinate 46 has been displaced medially. A sharp dissector 64is introduced into nasal cavity 38 and used to perforate lateral nasalwall 44 in the inferior meatus 52 to create an opening 56 in lateralnasal wall 44 (FIG. 8). Dissector 64 is withdrawn from nasal cavity 38.The deflated balloon catheter 130 is introduced into the nasal cavity38, and distal segment 137 of balloon catheter 130 is pushed throughopening 56 in lateral nasal wall 44. The balloon 134 is inflated to 9bars for 20 seconds then deflated. Deflated balloon 134 is slightlyrepositioned to assure total dilation of the opening 56. A seconddilation of the balloon 134 to a pressure of 9 bars for 20 seconds isperformed. The balloon catheter 130 is then deflated and withdrawn fromopening 56 and nasal cavity 38. The irrigation and suction functions ofthe catheter are used to irrigate off and suction away blood, pus andother debris from the surrounding tissues, while the endoscope functionprovides good visualization for the surgeon.

A balloon catheter ethmoidectomy of the anterior ethmoid sinus is shownin FIGS. 10-12. The middle turbinate 20 (FIG. 5) has been retractedmedially to gain access to the middle meatus 22 (FIG. 5). In some cases,the middle turbinate may be partially or totally removed. The ethmoidinfundibulum 24 is exposed by removing part of the uncinate process 26(FIG. 4). A fine cutting forceps 66 is used to remove the anterior wall30 of the ethmoid bulla 28 (FIG. 10). After anterior wall 30 of ethmoidbulla 28 is removed, the straight balloon catheter 230 is brought intonasal cavity 38, and distal segment 237 is pushed into bulla 28 (FIG.11). In some cases, the catheter can be pushed directly into the sinuswithout removing the anterior wall or the uncinate process. Theirrigation and suction functions of the catheter are used to irrigateoff and suction away blood, pus, a mucocele, if present, and otherdebris from the surrounding tissues and endoscope, while the endoscopefunction provides good visualization for the surgeon. The balloon 234 isinflated to 9 bars for 20 seconds then deflated. The catheter 230 isthen withdrawn from bulla 28. The distal segment 237 of balloon catheter230 is then pushed into the anterior ethmoid air cells 29 which lieposterior to the previously removed ethmoid bulla 28 (FIG. 12). Theballoon 234 is inflated to 9 bars for 20 seconds then deflated. Ballooncatheter 230 is then slightly repositioned to insure thorough dilationand inflated again to 9 bars for 20 seconds, deflated, and removed fromthe area of anterior ethmoid cells 29. Again the irrigation and suctionfunctions of the catheter are used to irrigate off and suction awayblood, pus, a mucocele, if present, and other debris from the relevantstructures, while the endoscope function provides good visualization forthe surgeon.

FIGS. 13 and 14 illustrate an ethmoidectomy of the posterior ethmoidsinus. When the posterior ethmoid sinus cells 31 must be removed, thebasal lamella 32 of the middle turbinate 20 is perforated with a punch68 (FIG. 13). Distal segment 237 of balloon catheter 230 is then pushedthrough the new opening 34 in the basal lamella 32 of the middleturbinate 20 into the posterior ethmoid air cells 31 and inflated 9 barsfor 20 seconds (FIG. 14). In some cases the catheter may be pusheddirectly into the posterior ethmoid sinus without first perforating witha punch. The balloon catheter 230 is then deflated, slightlyrepositioned, and again inflated 9 bars for 20 seconds. The ballooncatheter 230 is then deflated and withdrawn. The irrigation and suctionfunctions of the catheter are used to irrigate off and suction awayblood, pus, a mucocele, if present, and other debris from thesurrounding tissues, while the endoscope function provides goodvisualization for the surgeon.

FIG. 15 shows sinusotomy of the sphenoid sinus. After anterior andposterior ethmoidectomy, distal segment 237 of balloon catheter 230 isinserted through the anterior wall 37 of sphenoid sinus 39 (FIG. 15). Insome cases the catheter can be placed in the sphenoid sinus withoutfirst performing an ethmoidectomy. The balloon 234 is then inflated to 9bars for 20 seconds then deflated. The balloon catheter 230 is slightlyrepositioned to insure thorough dilation and inflated again to 9 barsfor 20 seconds, then deflated, and withdrawn. The irrigation and suctionfunctions of the catheter are used to irrigate off and suction awayblood, pus, a mucocele, if present, and other debris from the relevantstructures, while the endoscope function provides good visualization forthe surgeon.

FIG. 16 illustrates sinusotomy of the frontal sinus. After an anteriorethmoidectomy the nasofrontal duct 36 is exposed and in the surgeon'sview. The distal segment 137 of an angled catheter 130 with a 5 mminflated working diameter is brought into the frontonasal duct 36 andinflated to 9 bars, then deflated. In some cases the catheter can beplaced into the frontonasal duct and sinus without first performing anethmoidectomy. The distal segment 137 of the balloon catheter 130 isslightly repositioned to insure complete dilation of the nasofrontalduct 36 and inflated to 9 bars for 20 seconds then deflated andwithdrawn. The irrigation and suction functions of the catheter are usedto irrigate off and suction away blood, pus, a mucocele, if present, andother debris from the surrounding tissues, while the endoscope functionprovides good visualization for the surgeon.

FIG. 17 illustrates balloon catheter dilation of the choana, theposterior opening to the nasal cavity. This procedure can be useful fortreating choanal stenosis (narrowing of the choana), and choanalatresia. The distal segment 137 of the balloon catheter 130 ispositioned in the choana 299 and inflated to 8 bars for 30 seconds thendeflated and withdrawn. The irrigation and suction functions of thecatheter are used to irrigate off and suction away blood, pus and otherdebris from the surrounding tissues, while the endoscope functionprovides good visualization for the surgeon.

All of the above procedures may be performed in a similar fashion inpatients who have had previous sinus surgery and the sinus openings havebeen obstructed by scar tissue or granulation tissue.

While the preferred embodiment of the invention has been described,modifications can be made and other embodiments may be devised withoutdeparting from the spirit of the invention and the scope of the appendedclaims.

What is claimed is:
 1. A method of treating a patient's nasal sinuses,comprising: providing a balloon catheter having: an oblong body having aproximal segment and a distal segment, an expandable balloon located onsaid distal segment, and, a first conduit having a first distal nozzle;carrying an endoscope in said first conduit; pushing said distal segmentwith said balloon deflated into a space associated with a nasal sinus ofsaid patient; irrigating said space through said first conduit; and,inflating said balloon to dilate said space; wherein said space is themaxillary ostium of the patient's maxillary sinus, said distal segmentwith said balloon deflated being pushed through said maxillary ostiuminto said maxillary sinus, said maxillary ostium being dilated when saidinflatable member is inflated to complete antrostomy of said maxillaryostium; wherein prior to said step of pushing said distal segmentthrough said maxillary ostium, said method further comprises: mediallyretracting the patient's middle turbinate to gain access to thepatient's middle meatus; and, exposing the patient's ethmoidinfundibulum by removing part of the patient's uncinate process; whereinsaid endoscope has a minimum bend radius, and wherein said methodfurther comprises bending said body to have a bend not greater than saidminimum bend radius.
 2. The method of claim 1, which further comprises:inserting said endoscope through said first conduit.
 3. The method ofclaim 1, which further comprises: visualizing said space with saidendoscope.
 4. The method of claim 3, wherein said visualizing occursduring said pushing.
 5. The method of claim 3, wherein said visualizingoccurs during said irrigating.
 6. The method of claim 3, wherein saidvisualizing occurs during said inflating.
 7. The method of claim 1,which further comprises: forming a cutaway in said first conduitproximal to said first nozzle.
 8. The method of claim 1, which furthercomprises: orienting said endoscope with respect to said catheter. 9.The method of claim 1, which further comprises: angularly orienting saidendoscope with respect to said catheter.
 10. The method of claim 1,which further comprises suctioning debris from said nasal sinus throughsaid first conduit.
 11. The method of claim 10, which further comprisesirrigating said nasal sinus through said first conduit at a time whensaid suctioning is not occurring.
 12. The method of claim 1, whichfurther comprises: a second conduit having a second distal nozzle. 13.The method of claim 12, which further comprises: said first and secondnozzles being located distally from said balloon.
 14. The method ofclaim 12, which further comprises: said balloon surrounding said firstand second conduits.
 15. The method of claim 12, wherein said ballooncatheter further comprises a third conduit, and wherein said methodfurther comprises: suctioning debris from said nasal sinus through saidsecond conduit; and, inflating said balloon through said third conduit.16. The method of claim 1, wherein said body is flexible, and saidmethod further comprises fitting said body onto a rigidizing memberhaving sufficient stiffness and column strength to enable said catheter,when said balloon is deflated, to be pushed into said space of saidnasal sinus system.
 17. The method of claim 16, wherein said catheterfurther comprises a third conduit having a constricted distal openingsized to prevent passage of said rigidizing member therethrough.
 18. Themethod of claim 16, which further comprises: removing said rigidizingmember after said pushing.